Sleep and Depression in Induction of Labour

Sponsor

Turku University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03380897

Collaborator

University of Turku (Other)

117

Enrollment

Location

Arms

30.8

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Randomised trial comparing double balloon catheter for induction of labor between inpatient and outpatient groups. The investigators assess how sleep disturbances and depression of the mother affect to the pain during balloon catheter induction of labour.

Condition or Disease	Intervention/Treatment	Phase
Prolonged Pregnancy Sleep Disturbance Depression	Other: Intervention for outpatient group was to go home Other: Intervention for inpatient group was to stay at ward	N/A

Detailed Description

Participants included to this randomised study are women with uncomplicated singleton pregnancy with ≥ 37- ≤ 41+5 weeks of gestation. Participants are randomised to two groups: one hundred are randomised to the inpatient and one hundred to the outpatient group.

The main outcome measure is the pain evaluated by VAS at one, five , nine and 13 hours after the placement of double balloon induction catheter. The investigators assess also the effect of the sleep disturbance and depression of the mother to the pain during balloon catheter induction of the labour.

The total hospital stay and induction to delivery interval time is measured. Also the mode of birth as well as maternal and neonatal morbidity and patient satisfaction are recorded.

Study Design

Study Type:

Interventional

Actual Enrollment :

117 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

Factorial assignmentFactorial assignment

Masking:

None (Open Label)

Masking Description:

Open Label

Primary Purpose:

Health Services Research

Official Title:

Sleep Disturbances and Depression of the Mother Affect to the Pain During Balloon Catheter Induction of Labour

Actual Study Start Date :

Jun 7, 2017

Actual Primary Completion Date :

Dec 30, 2019

Actual Study Completion Date :

Dec 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Outpatient group After insertion of induction catheter for labor, women of the outpatient group can go home and assess their pain with visual analogy scale at home. The intervention is to go home. Intervention for outpatient group was to go home.	Other: Intervention for outpatient group was to go home Intervention for outpatient group was to go home and assess the the pain Other Names: Intervention was to assess the pain by visual analogy scale.
Placebo Comparator: Inpatient group After insertion of induction catheter for labor, women of the inpatient group assess their pain with visual analogy scale in the ward. The intervention is to stay at ward. Intervention for inpatient group was to stay at ward.	Other: Intervention for inpatient group was to stay at ward Intervention for inpatient group was to stay at ward and assess the pain Other Names: Intervention was to assess the pain by visual analogy scale.

Arm

Intervention/Treatment

Active Comparator: Outpatient group

After insertion of induction catheter for labor, women of the outpatient group can go home and assess their pain with visual analogy scale at home. The intervention is to go home. Intervention for outpatient group was to go home.

Other: Intervention for outpatient group was to go home

Intervention for outpatient group was to go home and assess the the pain

Other Names:

Intervention was to assess the pain by visual analogy scale.

Placebo Comparator: Inpatient group

After insertion of induction catheter for labor, women of the inpatient group assess their pain with visual analogy scale in the ward. The intervention is to stay at ward. Intervention for inpatient group was to stay at ward.

Other: Intervention for inpatient group was to stay at ward

Intervention for inpatient group was to stay at ward and assess the pain

Other Names:

Intervention was to assess the pain by visual analogy scale.

Outcome Measures

Primary Outcome Measures

The pain measured by VAS [one to 14 days after induction of the labor]
The pain measured by VAS after double balloon catheter insertion.

Secondary Outcome Measures

The affect of the sleep disturbances of the mother to the pain assessed by VAS [one to 14 days after induction of the labor]
The affect of the sleep disturbances to the pain assessed by VAS
The effect of depression of the mother to the pain assessed by VAS [one to 14 days after induction of the labor]
The effect of depression of the mother to the pain assessed by VAS
The total hospital stay in both groups [one to 14 days after induction of the labor]
The total hospital stay in both groups
The maternal and neonatal morbidity after balloon catheter induction [one to 14 days after induction of the labor]
The maternal and neonatal morbidity after balloon catheter induction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

uncomplicated pregnancy
singleton pregnancy
pregnancy weeks ≥ 37 - ≤ 41+5
the patient is living in1/2 hour away from hospital

Exclusion Criteria:

patient has a disease that is effecting to the pregnancy e.g. pre-eclampsia, gestational hepatosis
the patient has medical treatment of diabetes
baby is not growing normally
multiple pregnancy
preterm rupture of membranes
earlier caesarean section
the patient is living more than 1/2 hour away from hospital